UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057166 |
|---|---|
| Receipt number | R000065332 |
| Scientific Title | Verification of the effects of ORS intake on urination during dehydration after exercise.: Open-label crossover comparative study |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/27 15:37:06 |
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Basic information
Public title
Verification of the effects of ORS intake on urination during dehydration after exercise.
Acronym
Verification of the effects of ORS intake on urination during dehydration after exercise.
Scientific Title
Verification of the effects of ORS intake on urination during dehydration after exercise.: Open-label crossover comparative study
Scientific Title:Acronym
Verification of the effects of ORS intake on urination during dehydration after exercise.: Open-label crossover comparative study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how differences in fluid intake affect the body in a dehydrated state caused by exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total urine volume at the end of the observation period.
Key secondary outcomes
Body weight
Body temperature
Amount of sweating
Serum osmolality
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food
Interventions/Control_2
Consumption of control food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 18 to 30
(2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Subjects with a history of diabetes mellitus, liver disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious diseases.
(2) Subjects who have undergone gastrointestinal surgery
(3) Subjects showing abnormal liver and kidney function test values.
(4) Subjects who are allergic to food and drugs
(5) Subjects with anemia symptoms
(6) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(7) Subjects with extremely irregular eating habits
(8) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period
(9) Subjects who are continuously treated with medications (including OTC, prescription drugs)
(10) Subjects who drink more than 40g of ayarage daily pure alcohol
(11) Subjects who smoke an average of 21 or more cigarettes a day
(12) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study.
(13) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiyonori |
| Middle name | |
| Last name | Tomiwa |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Orthopedics
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06615355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065332
